Description

At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today’s therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, thoughtful risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions. 

The Clinical Trial Associate (CTA) is a critical member of the project team. The CTA assists the Clinical Operations Team with all aspects in the administration relating to clinical trial conduct according to International Conference of Harmonization (ICH), Good Clinical Practice (GCP), Code of Federal Regulations (CFR) and company Standard Operating Procedures (SOP). The CTA assist the Clinical Operations Team with the management of clinical studies from study implementation (start-up) to study close-out. 

Some or all of the responsibilities may be delegated to a Contract Research Organization (CRO).

This role is based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule. Remote work is allowed, and the frequency is at the discretion of management.

Responsibilities:

• Maintaining the Trial Master File (TMF) and assisting with site management, initiating the distribution, collection, handling, reviewing, tracking and archiving of essential documents throughout the lifecycle of clinical studies; this includes managing the filing indexes and maintaining current lists of correspondence; ensures completeness of, conducts regular audits of, organizes and archives clinical Trial Master File documents, including clinical study site documents, email correspondence, training materials and other study documents; participates in TMF or study audits as request and assists with responding to findings.
• Assists the study teams with site communications for various purposes – this includes feasibility/site identification activities and site updates
• Performs study start-up activities which includes but is not limited to review of informed consents, development and review of study reference plans and manuals; distribute, collect and conduct quality review of clinical study site documents
• Responsible for the submission of study documents to ethics committee and/or competent authorities; works as a liaison with review boards and independent ethics committees in the regulatory approval process.
• Assists with the creation and maintenance of study-specific documents, tools and materials and the procurement of study supplies.
• Provides study materials and supplies to the study sites and Clinical Research Associates (CRAs).
• Assists with tracking of clinical study progress including the creation and maintenance of study related trackers and status reports
• Participates in clinical team meetings – coordinates teleconferences / webinar and assists with the preparation of agendas, minutes and tracking of action items 
• Prepares for and attends Investigator Meetings, as required. May participate in clinical vendor selection process, as required.
• Performs review of clinical data listings, as required
• Under general supervision, manage third party vendors in the every-day conduct of a clinical trial (central lab, reading center, IRB)
• May act as mentor and train less experienced CTAs.
• Maintains completion of company and study-specific trainings such as SOPs, policies, study plans and documents by due date
• May participate and contribute to the implementation of process improvements to support study teams, department or the company (e.g. SOPs)
• Assist with other duties and projects, as needed

Requirements

• Undergraduate degree or its international equivalent in clinical, science or health-related field with a minimum of 2 years' clinical research experience with a pharmaceutical, biotechnology, or contract research organization (CRO). 
• Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form.
• Demonstrate high ethical standards for honesty, truthfulness and integrity.
• Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and ICH guidelines, as well as basic understanding of the phases of clinical drug development and clinical operation processes. 
• Ability to receive general instructions on all new assignments and perform routine work with minimal or no supervision.
• Strong sense of urgency, organizational skills with attention to detail and ability to follow through on assigned tasks. 
• Proficiency in computer literacy in several software packages, especially Microsoft Office applications (Word, Excel) and database software (eTMF, EDC) to support operation of clinical trial databases and electronic filing methods. 
• Enthusiastic team player and ability to work effectively in a team/matrix environment
• Ability to handle multiple tasks and deliver assigned tasks with quality and within specified timelines
• The salary range for this position is commensurate with experience.

Viridian offers a comprehensive benefits package including:

• Competitive pay and stock options for all employees
• Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
• Fertility and mental health programs
• Short- and long-term disability coverage
• Life, Travel and AD&D
• 401(k) Company Match with immediate company vest
• Employee Stock Purchase plan
• Generous vacation plan and paid company holiday shutdowns
• Various mental, financial, and proactive physical health programs covered by Viridian

Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.